Package Insert: Information for the User

Pramipexol Aurovitas Spain 2.1 mg Extended-Release Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again
• If you have any questions, consult your doctor or pharmacist
• This medication has been prescribed only for you, and you should not give it to otherseven if they have the same symptoms as you, as it may harm them
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Pramipexol contains the active ingredient pramipexol and belongs to a group of medicines called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain that help control the body's movements.

PramipexolAurovitas Spainis used for:

- treating the symptoms of idiopathic Parkinson's disease in adults. It may be used alone or in combination with levodopa (another medicine for Parkinson's disease).

Do not take Pramipexol Aurovitas Spain

If you are allergic to pramipexol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pramipexol Aurovitas Spain.Inform your doctor if you have or have had any disease or symptom, especially any of the following:

• Kidney disease.
• Hallucinations (seeing, hearing, or feeling things that are not present). Most hallucinations are visual.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs). If you have advanced Parkinson's disease and are also using levodopa, you may experience dyskinesia during the progressive increase in the dose of Pramipexol Aurovitas Spain.
• Dystonia (inability to maintain the trunk and neck straight and upright [axial dystonia]). Specifically, you may experience forward flexion of the head and neck (also known as antecolis), forward curvature of the lumbar region (also known as camptocormia), or lateral curvature of the back (also known as pleurototonos or Pisa syndrome).
• Drowsiness and sudden sleep episodes.
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual disturbances. You should undergo periodic eye examinations during treatment with Pramipexol Aurovitas Spain..
• Severe heart or blood vessel disease. You should undergo periodic blood pressure checks, especially at the beginning of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in an unusual way in you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as excessive gaming, eating, or spending, abnormally high sex drive with increased sexual thoughts and feelings.You may need your doctor to adjust your dose or discontinue treatment.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (diminished consciousness, confusion, or loss of contact with reality).You may need your doctor to adjust your dose or discontinue treatment.

Inform your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with pramipexol. If the problems persist for more than a few weeks, you may need your doctor to adjust your treatment.

Inform your doctor if you are noticing inability to maintain the trunk and neck straight and upright (axial dystonia). In this case, your doctor may decide to adjust or modify your treatment.

Pramipexol Aurovitas Spainextended-release tablets are specially designed tablets that release the active ingredient gradually once the tablet is ingested. In some cases, parts of the tablets may be excreted and appear in the stool, which may look like intact tablets. Inform your doctor if you find tablet fragments in your stool.

Children and adolescents

Pramipexol Aurovitas Spain is not recommended for use in children or adolescents under 18 years old.

Other medications andPramipexolAurovitas Spain

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This includes medications, herbal remedies, natural foods or nutritional supplements that you have obtained without a prescription.

You should avoid using Pramipexol Aurovitas Spain with antipsychotic medications.

Be cautious if you are using the following medications:

• cimetidine (for the treatment of excess acid and stomach ulcers);
• amantadine (which may be used in the treatment of Parkinson's disease);
• mexiletine (for the treatment of irregular heartbeats, a condition known as ventricular arrhythmia);
• zidovudine (which may be used to treat acquired immunodeficiency syndrome [AIDS], a human immunological disease);
• cisplatin (for treating various types of cancer);
• quinine (which may be used to prevent painful leg cramps that occur at night and to treat a type of malaria known as malignant malaria);
• procainamide (for treating irregular heartbeats).

If you are using levodopa, it is recommended to reduce the dose of levodopa when starting treatment with Pramipexol Aurovitas Spain.

Be cautious if you are using tranquilizing medications (with sedative effect) or if you drinkalcohol. In these casesPramipexol Aurovitas Spainmay affect your ability to drive and operate machinery.

Taking PramipexolAurovitas Spainwith food, drinks, and alcohol

You should be cautious if you drink alcohol during treatment with Pramipexol Aurovitas Spain.

You can take Pramipexol Aurovitas Spain with or without food.

Pregnancy,lactationandfertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.Your doctor will tell you if you should continue treatment with Pramipexol Aurovitas Spain.

Pramipexol Aurovitas Spain is not known to affect the fetus. Therefore, do not take Pramipexol Aurovitas Spain if you are pregnant unless your doctor tells you to.

Pramipexol Aurovitas Spain should not be used during breastfeeding. Pramipexol may decrease milk production. Additionally, it may pass into breast milk and reach your baby. If the use of Pramipexol Aurovitas Spain is necessary, breastfeeding should be discontinued. Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Pramipexol Aurovitas Spain may cause hallucinations (seeing, hearing, or feeling things that are not present). If this happens, do not drive or operate machinery.

Pramipexol has been associated with drowsiness and sudden sleep episodes, especially in patients with Parkinson's disease. If you experience these adverse effects, do not drive or operate machinery. Inform your doctor if this happens.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.Your doctor will indicate the correct dosage.

Take Pramipexol Aurovitas Spain prolonged-release tablets once a day and at the same hour every day.

You can take PramipexolAurovitas Spainwith or without food. The tablets must be swallowed whole with water.

Do not chew, break or crush the prolonged-release tablets. If you do, there is a risk of overdose, as the medication may be released in your body too quickly.

During the first week, the usual daily dose is 0.26 mg of pramipexol. This dose will be increased every 5-7 days according to your doctor's instructions until your symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.05 mg per day. However, it may be necessary to increase your dose further. If necessary, your doctor may increase your dose of tablets up to a maximum of 3.15 mg of pramipexol per day. It is also possible to reduce the maintenance dose to 1 prolonged-release tablet of Pramipexol Aurovitas Spain 0.26 mg per day.

Patients with kidney disease

If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26mg prolonged-release tablets every other day during the first week. After that, your doctor may increase the frequency of doses to 1 prolonged-release tablet of 0.26mg per day. If you need to increase your dose further, your doctor may adjust your dose in increments of 0.26mg of pramipexol.

If you have severe kidney disease, your doctor may consider it necessary to change to a different pramipexol medication. If during treatment your kidney problems worsen, contact your doctor as soon as possible.

When switching from Pramipexol Aurovitas Spain immediate-release tablets

Your doctor will base your dose of Pramipexol Aurovitas Spain prolonged-release tablets on the dose of Pramipexol Aurovitas Spain immediate-release tablets you were taking.

The day before the switch, take your pramipexol immediate-release tablets as you normally would. The next morning, take your pramipexol prolonged-release tablet and do not take any more pramipexol immediate-release tablets.

If you take more PramipexolAurovitas Spain than you should

If you accidentally ingest too many tablets:

• consult your doctor or the nearest hospital emergency service immediately
• you may experience vomiting, restlessness or any of the adverse effects described in section 4, “Possible adverse effects”.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Pramipexol Aurovitas Spain

If you forget to take your pramipexol dose but remember to take it within 12 hours of your usual time, take your tablet and continue with the next tablet at your usual time.

If you forget to take your dose more than 12 hours after the usual time, simply take the next dose at your usual time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Pramipexol Aurovitas Spain

Do not stop your treatment with PramipexolAurovitas Spainwithout consulting your doctor first. If you need to stop your treatment with this medication, your doctor will gradually reduce your dose. This reduces the risk of worsening your symptoms.

If you have Parkinson's disease, do not stop your treatment with PramipexolAurovitas Spainsuddenly. Sudden discontinuation may cause the appearance of a condition called neuroleptic malignant syndrome, which can pose a significant risk to your health. These symptoms include:

• akinesia (loss of muscle movement)
• muscle rigidity
• fever
• unstable blood pressure
• tachycardia (increased heart rate)
• confusion
• decreased level of consciousness (e.g. coma).

Stopping treatment or reducing the dose of Pramipexol Aurovitas Spain may also cause a medical condition called dopamine agonist withdrawal syndrome.

The symptoms include depression, apathy, anxiety, fatigue, sweating or pain. If you experience these symptoms, you should contact your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The classification of side effects is based on the following frequencies:

You may experience the following side effects:

Very common:

• Dyskinesia (e.g. abnormal involuntary movements of the limbs)
• Drowsiness
• Dizziness
• Nausea

Common:

• Need to behave in an unusual way
• Illusions (seeing, hearing or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Low blood pressure
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (urge to vomit)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delusion
• Excessive daytime somnolence and sudden onset of sleep
• Amnesia (memory alteration)
• Hypokinesia (increase in movement and inability to remain still)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Syncope (fainting)
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles) *
• Inadequate secretion of the antidiuretic hormone *
• Restlessness
• Dyspnea (difficulty breathing)
• Hypophonia (low voice)
• Pneumonia (lung infection)
• Inability to resist the impulse, instinct or temptation to perform an action that may be harmful to you or others, which may include:

• Strong impulse to gamble excessively despite serious personal or family consequences
• Altered or increased sexual interest and concerning behavior for you or others, for example, increased libido
• Uncontrollable excessive spending
• Binge eating (ingestion of large amounts of food in a short period of time) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger) *

• Delirium (decreased consciousness, confusion, loss of contact with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)
• Spontaneous penile erection

Frequency not known:

• After interrupting or reducing treatment with pramipexol: may cause depression, apathy, anxiety, fatigue, sweating or pain (known as dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

For the side effects marked with * it is not possible to provide a precise estimate of the frequency, as these side effects were not observed in clinical trials involving 2,762 patients treated with pramipexol. The frequency category is likely not higher than "uncommon".

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Unused medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Pramipexol CompositionAurovitas Spain

The active ingredient is pramipexol. Each tablet contains 2.1 mg of pramipexol as 3 mg of dihydrochloride monohydrate of pramipexol.

The other components are:hypromellose,calcium phosphate dibasic, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and content of the packaging

Pramipexol Aurovitas Spain 2.1 mg are prolonged-release tablets, white or almost white, cylindrical, and biconvex, marked with 210 on one side. Each package contains 30 tablets.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for Manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9, 08173 Sant Cugat del Vallés, Barcelona (SPAIN)

OTHER PRESENTATIONS

PramipexolAurovitas Spain 0.26 mg prolonged-release tablets EFG.

PramipexolAurovitas Spain 1.05 mg prolonged-release tablets EFG.

Last review date of this leaflet: February 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/